Crohn's disease
Conditions
Interventions
Case series:None
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Adults aged 18 to 75 years old, regardless of gender; 2) Meet the CD diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Crohn's Disease in China (Guangzhou, 2023)"; 3) Patients with moderate to severe active CD who have poor response, intolerance or contraindications to one or more anti-TNF monoclonal antibodies (CDAI > 220 points, SES-CD endoscopic score > 6 points); 4) Voluntarily agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Combined with ulcerative colitis or indeterminate colitis; 2) Chronic infectious diseases in active stage; 3) Those with tumors (excluding those whose tumors have been cured in the past); 4) Combined with coagulation dysfunction or thromboembolic disease (acute myocardial infarction, cerebral infarction/embolism, pulmonary embolism or thromboembolism in other parts within six months), liver and kidney insufficiency, severe cardiopulmonary insufficiency and other diseases; 5) A history of allergic reaction or significant allergy to the ingredients of the study drug (and its excipients) and/or other similar products; 6) The researchers believe that patients who are not suitable to participate in this study are pregnant and lactating women; 7) Vaccinated live vaccines within the past month; 8) Received fecal bacterial transplant within the past month; 9) Patients who have received biological agents (including infliximab, vedelizumab, ustekinumab, etc.) within the past three months; 10) Patients who are considered by the investigator to be unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical response rate;Clinical remission rate;Endoscopic response rate;Endoscopic remission rate;Mucosal healing rate;Transmural healing rate;Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic characteristics;Laboratory examination;Imaging data (intestinal ultrasound, CT enterography, etc); | — |
Countries
China
Contacts
Public ContactWei Han
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed